- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03104231
VR-3D Movie-based Education
7. juni 2017 opdateret af: Marcin Grabowski, Medical University of Warsaw
OCULUS: a 3-D Movie to Improve Patient Compliance
Atrial fibrillation (AF), which is the most common cardiac arrhythmia in adults, is associated with a high risk of stroke and other thromboembolic complications.
The usage of oral anticoagulation (OAC) may prevent the incidence of the thromboembolic events in the majority of patients.
The current guidelines for the management of AF patients highlight the important role of patients' education, since the clinical benefit from OAC treatment may be achieved by the effective cooperation between patients and physicians.
It has been suggested, that compliance may be increased by the novel e-solutions introduced into the daily clinical practice.
Due to the improvement in advanced technologies, the virtual reality (VR) three-dimensional (3D) movie stands for a future alternative in e-medicine.
The aim of the OCULUS study was to examine whether the 3D movie-based knowledge transfer is effective in teaching patients about the consequences of AF and pharmacological possibilities in reducing the risk of stroke.
Studieoversigt
Detaljeret beskrivelse
The OCULUS is a prospective, single centre study.
The study will include hospitalized patients, who are over 18 years old.
The only exclusion criteria of the study is the previously diagnosed dementia.
The study is based on the questionnaire designed by the authors of the study, enclosing questions about sex, age, education, current job, AF history and knowledge about consequences of AF and the possibility of stroke prevention due to the OAC therapy.
Subsequently, the brief VR-3D will be shown using the oculus glasses and a smartphone.
The movie's plot informs about the risk of stroke and importance of the OAC therapy to prevent the incidence of the thromboembolic complications of AF.
Consequently, patients will be asked several questions, including what was the movie about, whether AF can affect patient's life in a negative way, is it possible to reduce the risk of stroke and by what kind of drugs.
Similar questions will be asked to the patients immediately after the movie, one week and one year later, via the Telephone follow-up.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Warsaw, Polen, 02-097
- Paweł Balsam
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- >18 years old
- signed written informed consent
Exclusion Criteria:
- previously diagnosed dementia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: study group
All the patients will be shown three-dimensional (3D) movie.
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Brief VR-3D will be shown using the oculus glasses and a smartphone.
Then, patients will be asked several questions from the prepared questionnaire.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Assessment of the effectiveness of the 3D-movie based knowledge transfer in teaching patients about the consequences of AF
Tidsramme: 1 year
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The outcome will be assessed by questionnaire designed by the authors of the study, enclosing questions about sex, age, education, current job, AF history and knowledge about consequences of AF and the possibility of stroke prevention due to the OAC therapy.
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1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Paweł Balsam, MD, PhD, 1st Chair and Department of Cardiology, Medical University of Warsaw, Warsaw, Poland
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2016
Primær færdiggørelse (Faktiske)
30. april 2017
Studieafslutning (Faktiske)
30. maj 2017
Datoer for studieregistrering
Først indsendt
28. marts 2017
Først indsendt, der opfyldte QC-kriterier
31. marts 2017
Først opslået (Faktiske)
7. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- OCULUS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
We will be able to share all of the data.
They will be available on april 2017th.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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